(49 days)
No
The document does not mention AI, ML, or any related terms, and the device description focuses on hardware and standard digital imaging features.
No
The device is intended for taking "diagnostic radiographic exposures," indicating its use for diagnosis, not therapy.
Yes
The device is explicitly described as "taking diagnostic radiographic exposures" and is intended for use by a "qualified/trained doctor or technician" to image various body parts. It also mentions "diagnostic image quality."
No
The device description explicitly states it is a "fully motorized mobile DR system" and mentions hardware components like a "viewing monitor" and "front-view camera," indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the ddrCruze™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use of the ddrCruze™ is to take diagnostic radiographic exposures of various body parts directly on the patient. It does not involve analyzing blood, urine, tissue, or any other biological samples.
- The description focuses on imaging technology and patient positioning. The device description details a mobile DR system, wireless connectivity, image quality, and maneuverability, all related to capturing X-ray images of the patient.
- The anatomical sites are parts of the living body. The intended use specifies imaging the skull, spinal column, chest, abdomen, extremities, and other body parts, which are all in vivo applications.
Therefore, the ddrCruze™ is a medical imaging device used for diagnostic radiography, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ddRCruze™ is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
Product codes
MQB, IZL
Device Description
This represents the combination of the two of the predicate devices: K101517, Sedecal Mobile Digital Diagnostic X-Ray Systems (various models), manufactured by Sedecal SA (Spain), Software: PrestoDR Portable, K100400, CMT Medical Technologies LTD. (Used UNMODIFIED). ddRCruze™ features a fully motorized mobile DR system, wireless connectivity, diagnostic image quality, viewing monitor for image review and system setup which can be positioned on any side of the system for added convenience. The system has a front-view camera for safe maneuverability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts.
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The unit has undergone electrical safety and electromagnetic compatibility testing, as well as system integration testing. The technical characteristics of the panel have been measured and included in the bench testing information. Not applicable for clinical tests as both the mobile system and the digital panel, as well as the software has been previously cleared and is provided unmodified.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) Summary
- Submitter: Swissrav Medical AG . Turbistrasse 25 – 27 CH-6280 Hochdorf, Switzerland Phone +41 41 914 12 12 Fax +41 41 914 12 13 Date Prepared: February 6, 2013 Contact: Markus Bütler, Quality Manager
JUN 2 5 2013
-
- Identification of the Device: ddRCruze™ (Digital Mobile Diagnostic X-Ray System); Recommended classification regulation: 21 CFR 892.1650, 892. 1720 Device class: 11, Panel: Radiology, Product code: MQB and IZL
-
- A description of the device: This represents the combination of the two of the predicate devices: K101517, Sedecal Mobile Digital Diagnostic X-Ray Systems (various models), manufactured by Sedecal SA (Spain), Software: PrestoDR Portable, K100400, CMT Medical Technologies LTD. (Used UNMODIFIED ). ddRCruze™ features a fully motorized mobile DR system, wireless connectivity, diagnostic image quality, viewing monitor for image review and system setup which can be positioned on any side of the system for added convenience. The system has a front-view camera for safe maneuverability.
- Intended for use by a qualified/trained doctor or technician on both 5. Intended use of the device: adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography) (SAME as predicate)
| Characteristic | Predicate Device
K101517, Sedecal Mobile Digital
Diagnostic X-Ray Systems
(various models),. | PrestoDR Portable, K100400,
CMT Medical Technologies
LTD. | New Device ddRCruze™ |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Intended for use by a
qualified/trained doctor or
technician on both adult and
pediatric subjects for taking
diagnostic radiographic
exposures of the skull, spinal
column, chest, abdomen,
extremities, and other body
parts. Applications can be
performed with the patient
sitting, standing, or lying in the
prone or supine position. (Not
for mammography) | The PrestoDR Portable, is
intended for use in general
radiographic examinations,
wherever conventional screen-
film systems may be used,
excluding fluoroscopy,
angiography and
mammography. PrestoDR 4143
allows imaging of the skull,
chest, shoulders, spine,
abdomen, and extremities. | Intended for use by a
qualified/trained doctor or
technician on both adult and
pediatric subjects for taking
diagnostic radiographic exposures
of the skull, spinal column, chest,
abdomen, extremities, and other
body parts. Applications can be
performed with the patient
sitting, standing, or lying in the
prone or supine position. (Not
for mammography) (SAME) |
| Characteristic | Predicate Device
K101517, Sedecal Mobile Digital
Diagnostic X-Ray Systems
(various models),. | PrestoDR Portable, K100400,
' CMT Medical Technologies
LTD. | New Device ddRCruze™ |
| Digital Receptor
Panel(s) | Pixium PORTABLE 3543pR:
Pixium* Csl coupled to TFT matrix
a:Si-technology
Pixel size 144 μm
Matrix size 2372 x 3000 pixels
16 bit gray scale | Pixium RAD 4600+ and/or
Pixium Portable 3543 (WiFi or
Cabled) Pixium© Csl on
amorphous silicon technology
144 mm 17x14 inch (43.2x34.2
cm) 3,000 x 2,372 pixels
16 bit gray scale | Pixium Portable 3543 EZ
Technology Single A-Si TFT +
photodiode plate, Csl Scintillator.
Active detector area 43 cm x 43
cm, Spatial resolution 3.5 lp/mm
Active pixel matrix 2880 x 2880
pixels, Pixel size 148 μm
16 bit gray scale (Cleared in our
own 510(k): K123005, ddRVersa
Motion.) |
| Panel Operating
Time (battery
life) | 2 Hours | Up to 8 hours | Up to 8 hours |
| Panel
Communication | Tethered Ethernet or WiFi | Tethered Ethernet or WiFi | Tethered Ethernet or WiFi |
| Generator | 20 kW 32 kW 40 kW 50 kW | Not included | 20 kW 32 kW 40 kW 50 kW |
| Safety | UL Listings and IEC Standards IEC
60601-1 and IEC 60601-1-2, US
Performance Standards | UL/CSA Listings and IEC
Standards IEC 60601-1 and IEC
60601-1-2, US Performance
Standards | UL/CSA Listings and IEC Standards
IEC 60601-1 and IEC 60601-1-2,
US Performance Standards |
| Photo | Image: Sedecal Mobile Digital Diagnostic X-Ray Systems | Image: CMT Medical Technologies LTD | Image: New Device ddRCruze |
Comnarison Table
1
- ર્દ . Description of non-clinical tests. The unit has undergone electrical safety and electromagnetic compatibility testing, as well as system integration testing. The technical characteristics of the panel have been measured and included in the bench testing information.
-
- Description of clinical tests: Not applicable. Both the mobile system and the digital panel, as well as the software has been previously cleared and is provided unmodified.
-
- Conclusions drawn: The nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 3, above.
2
Image /page/2/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center is a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0003
June 25, 2013
Swissray Medical AG % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LL.C. 1394 25th Street NW BUFFALO MN 55313
Rc: K131314
Trade/Device Name: ddrCruzeTM Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB, IZL Dated: June 10, 2013 Received: June 11, 2013
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind vou, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. F.DA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
Page 2 - Mr. Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.ida.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sm.7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K131314
Device Name: ddrCruze™
Indications For Use:
The ddrCruze™ is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. {Not for mammography}
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K131314
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